• Contact Us
  • About Us
  • Log In or Create an Account
Menu
  • Contact Us
  • About Us
  • Log In or Create an Account

We’re here to help.

  • Toll Free: 866-205-9215
  • info@completelabsystems.com
×
$0.00 0 Cart
  • COVID-19 TESTS
  • CLIA Waived Rapid Tests
    • Drugs of Abuse
    • Alcohol Testing
    • Drugs of Abuse ID Kits
    • Physician Office Lab
  • RT-PCR & Molecular
    • Automated Extraction
    • Manual Extraction
    • RT-PCR Analyzers
    • RT-PCR Panels & Reagents
  • CLIA Laboratory
    • Allergy
    • Chemistry
    • Hematology
    • Immunoassay
    • Toxicology
    • Open Channel Chemistry Reagents
    • General Chemistry Controls
  • Lab Consumables
    • Centrifuges & Tubes
      • Centrifuges
      • Centrifuge Tubes
    • ESR Products
    • Freezers & Refrigerators
    • Fume Hoods
    • Pipettes & Tips
      • Pipettes
      • Pipette Tips
    • Plates & Consumables
      • Extraction
      • RT-PCR
      • ELISA Plates
    • Sample Collection & Transport
      • Transport Medium
      • Swabs
      • Specimen Bags
    • Test Tubes & Tube Racks
      • Test Tubes - Plastic
      • Test Tubes - Glass
      • Tube Racks
Home / CLIA Waived Rapid Tests / Physician Office Lab / Infectious Disease
Status™ COVID-19/Flu

LifeSign

Status™ COVID-19/Flu A&B Test Kit- CLIA-Waived

$426.95

Add to Cart

Status™ COVID-19/FLU A&B is a Rapid Immunoassay for the Simultaneous Direct Detection and Differential Diagnosis of SARS-CoV-2, Influenza Type A and Type B Antigen from anterior nasal and nasopharyngeal swab specimens

 
 
 

description

Product Description

Status™ COVID-19/Flu test is a lateral flow immunoassay intended for the in vitro rapid,
simultaneous qualitative detection and differentiation of nucleocapsid antigen from SARS-CoV2, influenza A and influenza B directly from anterior nasal and nasopharyngeal swab specimens obtained from individuals, who are suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider, within the first five days of onset of symptoms. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high, or waived complexity tests.
This test is authorized for use at the Point of Care (POC), i.e., in patient care
settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

Kit Includes

25 Test Devices
25 Extraction Reagents in Capsules
25 Sterile Swabs
1 Positive and 1 Negative Control Swabs
1 Package insert
1 Quick Reference Instruction


Results Interpretation

Positive: Determination of a positive result is made at fifteen (15) minutes. A reddish purple Control line (C position) and a reddish purple Test line (Flu A, Flu B or CoV19 position) indicate that Influenza A, B and/or SARS-CoV-2 antigen has been detected. Lines at the A and C positions indicate the presence of Influenza type A viral antigen, lines at the B and C positions indicate the presence of Influenza type B viral antigen, and lines at the CoV19 and C positions indicate the presence of SARS-CoV-2 viral antigen in the specimen. A positive result does not rule out co-infections with other pathogens or identify any specific influenza A virus subtype.

Negative: A reddish purple Control line (C position) only, with no Test line at the A, B, CoV19 positions, indicates that Influenza A, B antigen or SARS-CoV-2 antigen has not been detected. A negative result does not exclude influenza viral or SARS-CoV-2 viral infection. Determination of negative results should not be made before 15 minutes.

Invalid: A reddish purple line should always appear at the Control line position (C
position). If a line does not form at the Control line position in 15 minutes, the test result
is invalid and the test should be repeated with a new Status™ COVID-19/Flu test device.

IMPORTANT: Please refer to package insert (instructions for use) for more comprehensive product information.


CPT Codes for COVID-19 and Flu A/B:

COVID-19: 87811QW
FLU A: 87804QW
FLU B: 87804QW-59


FEATURES & BENEFITS

  • COVID-19
    - Anterior nasal swab specimen − Sensitivity 93.8 %, Specificity 100%
    - Nasopharyngeal − Sensitivity 93.1 %, Specificity 100%
  • Flu A - Sensitivity 91.4%, Specificity 95.7%
  • Flu B - Sensitivity 87.6%, Specificity 95.9%
  • FDA Emergency Use Authorization (EUA)
  • Visually read in 15 minutes
  • Flocked nasopharyngeal swab for superior specimen collection and patient comfort

 

DOCUMENTATION

 

The Status COVID-19/Flu A&B Antigen Rapid Test Kit brochure, product insert, authorized Fact Sheet for Healthcare Providers, authorized Fact Sheet for Recipients and additional studies are provided below:

Expiration Dating Memo
Product Insert
Fact Sheet For Patients
Fact Sheet for Healthcare Providers
Procedure Card

 
  • Manufacturer Catalog #: 33225
  • SKU: CLS33225
  • Categories: COVID-19 TESTS, Infectious Disease

More Products

OSOM® Ultra Plus Flu A&B Test

Infectious Disease

OSOM® Ultra Plus Flu A&B Test

$270.86
OSOM® Ultra Flu A&B Test

Infectious Disease

OSOM® Ultra Flu A&B Test

$270.86
Sale!
InteliSwab COVID-19 Rapid Test

COVID-19 TESTS

InteliSwab COVID-19 Rapid Test (Over-The-Counter) 2 Pack

$23.99 $20.95
Life sign Status Flu Test Rapid Flu Test A +B Test Influenza A+ B Rapid Test Flu

Infectious Disease

Status Lifesign Rapid Flu A & B Test- 25 Tests/Kit

$231.02
COMPANY
  • About Us
  • Blog/News
  • Contact Us

CLIA WAIVED RAPID TESTS

  • Alcohol Testing
  • Drugs of Abuse Screening
  • Drugs of Abuse ID Kits
  • Physician Office Lab

CLIA LABORATORY

  • Clinical Lab
  • Toxicology
  • Molecular
  • Lab Consumables
CONTACT US
  • Local: 818-205-9221
  • Toll Free: 866-205-9215
  • info@completelabsystems.com

6320 Canoga Ave. Ste. 1500, FL 15
Woodland Hills, CA 91367

STAY CONNECTED
Facebook-f Twitter Youtube

SIGN UP FOR OUR NEWSLETTER

Terms and Conditions
Privacy Policy
Cookies
Do Not Sell My Info
Copyright © 2023 – Complete Laboratory Systems. All rights reserved.
    • COVID-19 TESTS
    • CLIA Waived Rapid Tests
      • Drugs of Abuse
      • Alcohol Testing
      • Drugs of Abuse ID Kits
      • Physician Office Lab
    • RT-PCR & Molecular
      • Automated Extraction
      • Manual Extraction
      • RT-PCR Analyzers
      • RT-PCR Panels & Reagents
    • CLIA Laboratory
      • Allergy
      • Chemistry
      • Hematology
      • Immunoassay
      • Toxicology
      • Open Channel Chemistry Reagents
      • General Chemistry Controls
    • Lab Consumables
      • Centrifuges & Tubes
        • Centrifuges
        • Centrifuge Tubes
      • ESR Products
      • Freezers & Refrigerators
      • Fume Hoods
      • Pipettes & Tips
        • Pipettes
        • Pipette Tips
      • Plates & Consumables
        • Extraction
        • RT-PCR
        • ELISA Plates
      • Sample Collection & Transport
        • Transport Medium
        • Swabs
        • Specimen Bags
      • Test Tubes & Tube Racks
        • Test Tubes - Plastic
        • Test Tubes - Glass
        • Tube Racks
  • Login
  • Newsletter

This website uses cookies to improve your experience. We'll assume you're ok with this, but you can opt-out if you wish. Read More

Accept

Cookie Settings

  • About Cookies

    About Cookies

    Cookies are small text files that can be used by websites to make a user's experience more efficient. The law states that we can store cookies on your device if they are strictly necessary for the operation of this site. For all other types of cookies we need your permission. This site uses different types of cookies. Some cookies are placed by third party services that appear on our pages.
  • Necessary

    Necessary

    Always Active
    Necessary cookies help make a website usable by enabling basic functions like page navigation and access to secure areas of the website. The website cannot function properly without these cookies.
    NameDomainPurposeExpiryType
    wpl_user_preference completelabsystems.com WP GDPR Cookie Consent Preferences 1 year HTTP
  • Marketing

    Marketing

    Marketing cookies are used to track visitors across websites. The intention is to display ads that are relevant and engaging for the individual user and thereby more valuable for publishers and third party advertisers.
  • Analytics

    Analytics

    Analytics cookies help website owners to understand how visitors interact with websites by collecting and reporting information anonymously.
    NameDomainPurposeExpiryType
    _gid completelabsystems.com Google Universal Analytics short-time unique user tracking identifier. 1 days HTTP
    _ga completelabsystems.com Google Universal Analytics long-time unique user tracking identifier. 2 years HTTP
  • Preferences

    Preferences

    Preference cookies enable a website to remember information that changes the way the website behaves or looks, like your preferred language or the region that you are in.
  • Unclassified

    Unclassified

    Unclassified cookies are cookies that we are in the process of classifying, together with the providers of individual cookies.
    NameDomainPurposeExpiryType
    _gat_gtag_UA_212460542_1 completelabsystems.com --- Session ---
    _ga_9YYXEQ0TN4 completelabsystems.com --- 2 years ---

Login

Lost your password?

Register

A password will be sent to your email address.

Your personal data will be used to support your experience throughout this website, to manage access to your account, and for other purposes described in our privacy policy.

Request Quote

  • This field is for validation purposes and should be left unchanged.